BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT ADJUSTABLE LENS (LAL)

    MDR report key: 14654233 · Received June 10, 2022

    Report

    Report Number
    3012712027-2022-00024
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    March 14, 2022
    Report Date
    June 9, 2022
    Manufacturer
    RXSIGHT, INC.
    Product Code
    PZK
    UDI-DI
    00818806020203
    PMA / PMN Number
    P160055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022. THE DEVICE HISTORY RECORD FOR THE LENSES WERE REVIEWED. NO ISSUES WERE NOTED. RIGHT EYE: SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001495, IMPLANT DATE: (B)(6) 2021, MFG DATE: 1/9/2020, EXPIRATION DATE: 12/31/2022, EXPLANT DATE: (B)(6) 2022, UDI: (B)(4). LEFT EYE: SERIAL NUMBER: (B)(4), LOT NUMBER: L02-001536, IMPLANT DATE: (B)(6) 2021, MFG DATE: 1/28/2020, EXPIRATION DATE: (B)(6) 2022, EXPLANT DATE: (B)(6) 2022, UDI: (B)(4). THE LENSES ARE IN THE PROCESS OF BEING RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022. THE LENSES WERE NOT SAVED AFTER EXPLANT. THE SITE DISCARDED THE LENSES.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022.

    Description of Event or Problem · 0

    SITE REPORTED BILATERAL PATIENT HAD LIGHT ADJUSTABLE LENSES EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725300 LIGHT ADJUSTABLE LENS (LAL) LIGHT ADJUSTABLE LENS (LAL) PZK RXSIGHT, INC. 60005 L02-001495 00818806020203

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention